Evaluation of Health Canada’s Medical Devices Program, 2020-2021 to 2024-2025

Final Report - Executive Summary and Management Response and Action Plan
February 2026
Prepared by the Office of Audit and Evaluation
Health Canada

On this page

• Executive summary
  • Background and evaluation scope
  • Key findings
  • Recommendations
• Management Response and Action Plan
  • Recommendation 1
  • Recommendation 2
  • Recommendation 3

Executive summary

Background and evaluation scope

Health Canada’s Medical Devices Program is responsible for ensuring that medical devices licenced for sale in Canada meet applicable safety, effectiveness, and quality requirements. The Program’s mandate is delivered under the authority of the Food and Drugs Act and its accompanying Medical Devices Regulations.

The implementation of the Program is a shared responsibility between Health Canada’s Health Products and Food Branch (HPFB) and its Regulatory Operations and Enforcement Branch (ROEB). To fulfill this mandate, the Program conducts pre-market reviews of device applications, monitors products in the post-market phase, and carries out compliance and enforcement activities. It also engages a wide range of stakeholders and plays a vital role in informing health care professionals and the public to support the safe and effective use of medical devices.

The Office of Audit and Evaluation (OAE) conducted this evaluation to assess the performance of the Medical Devices Program from April 2020 to March 2025. Multiple lines of evidence were used for this assessment, including:

• document and performance data reviews;
• interviews with internal and external stakeholders;
• financial analyses;
• case studies; and
• an online survey with external stakeholders.

The purpose of the evaluation was to examine the Program’s effectiveness and efficiency across its core functions: pre-market review, post-market surveillance, and compliance and enforcement. The assessment focused on the Program’s ability to inform the medical device industry and ensure regulatory compliance, communicate risks and benefits to stakeholders, and coordinate and collaborate effectively with partners. It also reviewed the Program’s operational efficiency, focusing on the clarity of its roles and responsibilities, whether the level of resources allocated was appropriate to meet the mandate, the suitability of tools to support Program activities, and its ability to adapt to emerging challenges.

Key findings

Effectiveness

The Program has helped ensure Canadians have access to medical devices that meet safety, effectiveness, and quality and regulatory requirements, while also facing some challenges and opportunities for improvement.

The Program effectively communicates with the medical devices industry and ensures its compliance with regulations. Using various channels, including guidance documents, consultations, and direct engagement, the Program informs the industry of its obligations. As a result of these efforts, compliance with regulatory requirements consistently met or surpassed target levels. At the same time, suggested improvements for industry outreach included increasing engagement with smaller companies, conducting more frequent outreach through webinars and training, making guidance documents easier to find online, and providing a single point of contact at Health Canada.

In fulfilling its regulatory role, the Program considers risk in its pre-market reviews and communicates its regulatory decisions through various tools (e.g., Regulatory Decision Summaries). In the post-market phase, it informs stakeholders and the public about device risks through channels like public advisories, recall notices, Health Product Risk Communications, and Health Product InfoWatch. However, the evaluation identified a need to improve the timeliness, clarity, accessibility, and consistent integration of Sex-and Gender-Based Analysis Plus (SGBA Plus) in some of these communications.

Collaboration with external partners emerged as a key strength, demonstrated by the Program maintaining strong relationships with various domestic partners through multiple formal channels. In addition, Health Canada worked closely with international regulators on priority issues like software as a medical device and the COVID-19 pandemic response.

Efficiency

The Program has not clearly defined, documented, or consistently communicated roles and responsibilities, particularly for cross-branch activities like surveillance and device classification issues that arise post-market, such as products being originally classified at one level, but further monitoring and compliance activities raise questions about the appropriateness of that classification. These issues underscore the need for coordinated decision making and clearer accountability across branches. Of note, the Program has begun addressing some of these issues, most significantly by developing a new device classification framework for ROEB and HPFB officials that outlines clear roles and responsibilities for classification issues arising post market.

Internal coordination and collaboration were found to be inconsistent and often reactive. This is largely due to siloed teams, which has led to a reliance on informal networks rather than established processes, governance bodies, and regular communications. Formal committees, like the Trilaterals at Manager and DG levels, and Medical Devices Program (MDP) Committee have not been used as much as possible as forums for strategic collaboration and decision making. Coordination challenges between the Program and the Digital Transformation Branch (DTB) have further affected the management and integration of the Program’s information technology (IT) systems. However, the Program and DTB have recently taken steps to improve collaboration.

Although the Program has met its regulatory mandate and generally meets cost-recovery targets, the evaluation noted capacity pressures in other areas, such as post-market surveillance and incident reporting, which can delay incident response and risk mitigation efforts.

The evaluation found that the Program’s information technology (IT) infrastructure is fragmented, with directorates operating separate, non-integrated tools, including the Adverse Reaction Information System – Global (ARIS-G), which is not suited for medical devices, and the Medical Device System (MDS), which was developed in-house. These weaknesses create data silos, require extensive manual data entry, and lead to backlogs and duplicated work.

The Program demonstrated agility in its response to the COVID-19 pandemic and emerging risks like software as a medical device, artificial intelligence, and cybersecurity. Health Canada introduced measures, including Interim Orders and Agile Licensing, to expedite approvals, reduce burden, and enhance responsiveness. This adaptability was sustained through regulatory amendments and initiatives showcased in Health Canada’s 2025 report on red tape reduction. However, challenges with IT systems and slow regulatory updates constrain the Program’s ability to stay flexible in the face of evolving risks and changes.

Recommendations

The evaluation findings point to challenges in role clarity, internal coordination, and IT systems and tools. The following recommendations address these issues.

Recommendation 1: Clarify and communicate internal roles and responsibilities across the Program, especially for ongoing device classification issues post market.

The evaluation found that, in the absence of clear and consistently communicated documentation, roles and responsibilities were not always well understood, especially for cross-branch activities like post-market surveillance and device classification challenges that arose post market due to ambiguous or non-existent pre-market classification statuses. This ambiguity contributed to operational inefficiency, including duplicated work and delays. Clarifying and formally documenting these responsibilities would help streamline processes, strengthen collaboration between branches, and reinforce the Program’s ability to respond to incidents in a timely and effective manner.

Recommendation 2: Strengthen internal coordination, collaboration, and communication across all Program partners.

The evaluation observed that collaboration within the Program, and with DTB, could benefit from a more proactive and structured engagement. This would help to alleviate operational silos and the limited use of formal governance bodies, which can hinder transparent and strategic decision making. Coordination issues between parties have also affected the efficiency and effectiveness of IT tools, further complicating Program operations. Strengthening internal coordination, collaboration, and communication through a more structured approach would help foster a unified and program-wide perspective, and ensure key partners are effectively engaged.

Recommendation 3: Explore opportunities to modernize tools to improve efficiency, enhance data integration across directorates, and adopt artificial intelligence and other innovative technologies.

The evaluation identified that the Program’s IT infrastructure is fragmented and relies on some tools not designed specifically for medical device oversight. This contributes to significant operational challenges, including data silos, backlogs from manual entry, and duplicated processes, which can delay incident processing and hinder coordinated regulatory decisions. Exploring opportunities to modernize these tools, streamline data integration, and adopt artificial intelligence and other innovative technologies would improve overall efficiency, accelerate incident processing, strengthen surveillance capacity, and support more effective regulatory analytics.

Management Response and Action Plan

Recommendation 1

Clarify and communicate internal roles and responsibilities across the Program, especially for ongoing device classification issues post-market.

Management response

Management agrees with Recommendation 1. Health Canada recognizes that clearly defined and documented roles and responsibilities with regards to pre-market and post-market activities, including cross-branch activities, will enhance efficiency and strengthen the Program’s capacity to address risks, classification challenges, and other regulatory obligations throughout the product life cycle.

Table 1: Action plan for Recommendation 1

Action Plan	Deliverables	Expected Completion Date	Accountability	Resources
Review and update the RACI (Responsible, Accountable, Consulted, or Informed) framework developed in 2021 by HPFB and ROEB to clarify and document roles and responsibilities across the Medical Devices Program (MDP).	Conduct a comprehensive assessment of the RACI framework to identify gaps and required updates, ensuring roles and responsibilities remain accurate and aligned with current processes. Document in the form of a briefing note to MDP’s DGs.	September 30, 2026	OPI: HPFB – MDD DG OSI: ROEB – MDCCD DG	Within existing resources
	Develop an updated RACI framework that reflects current roles, responsibilities, and processes for the MDP.	March 31, 2027	OPI: HPFB – MDD DG	Within existing resources
Review and update the Standard Operating Procedure on Directing Medical Devices enquiries.	Update the 2023 Standard Operating Procedure (SOP) on Directing Enquiries to reflect organizational changes, current roles and responsibilities and validate contact information. This SOP will be updated as necessary. Email SOP to staff.	September 30, 2026	OPI: HPFB – MDD DG HPFB – MHPD DG OSI: ROEB – MDCCD DG	Within existing resources
Communicate MDP’s RACI framework.	Present the finalized RACI framework to HPFB and ROEB Directorate Management Committees for endorsement and alignment. Meeting agenda and summary of discussion will be submitted.	March 31, 2027	OPI: HPFB – MDD DG HPFB – MHPD DG ROEB – MDCCD DG	Within existing resources
	Communicate and explain the updated RACI framework to all HPFB and ROEB staff involved in the MDP to ensure clarity of roles and responsibilities. This RACI will be updated as necessary. Email to staff.	June 30, 2027	OPI: HPFB – MDD DG HPFB – MHPD DG ROEB – MDCCD DG	Within existing resources
Develop framework for the classification of medical devices in the context of compliance and enforcement (i.e., post-market); supporting program-wide consistency in post-market device classification, and strengthening the Program’s capacity to address risks more efficiently.	ROEB Post-Market Classification Framework, including: inspector training, classification SOP (including defining responsibilities for program partners) and repository of decisions.	December 30, 2026	OPI: ROEB – MDCCD DG OSI: HPFB – MDD DG	Within existing resources

Recommendation 2

Strengthen internal coordination, collaboration, and communication across all Program partners.

Management response

Management agrees with Recommendation 2. Health Canada will continue to work towards the use of common information management databases and tools. Information management in one common system will enhance access to pre and post market medical device information by program partners throughout the device life cycle, allow for increased process automation and enable a coordinated approach across the Program. By consolidating data into one common technical platform, we eliminate systems silos within the medical devices program and help ensure that all program partners have timely, consistent access to critical medical device information throughout the entire life cycle.

Table 2: Action plan for Recommendation 2

Action Plan	Deliverables	Expected Completion Date	Accountability	Resources
Building on respective Branch planning processes, program partners will share plans and priorities.	Priority planning documents are shared amongst program partners via emails from Program Directors General.	June 30, 2026	OPI:  HPFB – MDD DG HPFB – MHPD DG ROEB – MDCCD DG OSI: DTB – DPDDM DG	Within existing resources
Plan and implement IP1102.	A Benefits Realization Plan that defines the specific benefits this initiative aims to deliver (e.g., improved integration, information sharing).	August 31, 2026	OPI: HPFB – MHPD DG OSI: HPFB – BFMD DG DTB – DPDDM DG	Within existing resources
	Business User sign off document to confirm completion of the specified requirements (see above).	August 31, 2026	OPI: HPFB –MHPD DG OSI: HPFB – BFMD DG DTB – DPDDM DG	Within existing resources
	Project Closeout Report to signal overall completion of IP1102.	March 31, 2027	OPI: HPFB –MHPD DG OSI: HPFB –BFMD DG DTB – DPDDM DG	Within existing resources

Recommendation 3

Explore opportunities to modernize tools to improve efficiency, enhance data integration across directorates, and adopt artificial intelligence and other innovative technologies.

Management response

Management agrees with Recommendation 3. There are plans underway at the Department and Branch levels to adopt and leverage artificial intelligence. This work will inform future actions meanwhile; IP1102 will integrate pre-market medical device data with post-market medical device data in a single IT system. This eliminate silos between areas of the program and integrates data into a single system and has been identified as a potential solution to address data management throughout the life cycle.

Table 3: Action plan for Recommendation 3

Action Plan	Deliverables	Expected Completion Date	Accountability	Resources
Explore opportunities to adopt artificial intelligence within Branch processes.	Present HPFB AI plan to Branch Executive Committee and share this plan with program partners.	April 30, 2026	OPI: HPFB – BFMD DG	Within existing resources
Explore opportunities for enhanced data integration within the Medical Devices Program IT systems.	Present IP1102 Project Management Plan to DG-Investment Plan governance.	May 31, 2026	OPI: HPFB – BFMD DG OSI: DTB – DPDDM DG HPFB – MHPD DG	Within existing resources